Identity
- Trade Name
- Matrix sleeve with fixing FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Matrix sleeve with fixing screw 1.4 mm Ø 2 Pieces each 4 Pieces FDA UDI
- Model / Reference
- 43007297 FDA UDI
- Description
- Matrix sleeve with fixing screw 1.4 mm Ø 2 Pieces each 4 Pieces FDA UDI
Identifiers
- Catalog Number
- 43007297 FDA UDI
- Primary DI / UDI-DI
- EBRE430072970 FDA UDI
- FDA Product Code
- EBL FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 5.3 Millimeter FDA UDIOuter Diameter — 2.8 Millimeter FDA UDI
Category: Screw endosteal dental implant, two-piece
Matrix sleeve with fixing by bredent GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- bredent GmbH & Co. KG
Sources (1)
- FDA UDI ad79f1bb-34a6-475f-9720-55064d99778b 36 fields · synced May 31, 2026